MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751761

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A health professional reported the surgeons hand was burned from the phacoemulsification handpiece.Procedure details or if surgeon required any treatment for the burn have not been provided.Additional information has been requested but not received.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The phacoemulsification (phaco) handpiece was received for evaluation.The returned phaco handpiece was connected to a calibrated system.A system message (sm) [tune failed ¿ loose tip] displayed when the phaco handpiece attempted tuning, and further testing could not be performed.Disassembling the phaco handpiece revealed moisture ingress within the electrode chamber.Unrelated to the reported event, moisture ingress was found to cause a short circuit from the high electrode to ground; however, how or when moisture entered the phaco handpiece remains inconclusive.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11071932
• MDR Text Key: 224341723
• Report Number: 2028159-2020-01154
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 03/29/2021; 04/22/2021
• Supplement Dates FDA Received: 03/29/2021; 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM